Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

Last updated: June 10, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Memory Loss

Mild Cognitive Impairment

Treatment

tACS device

Clinical Study ID

NCT05904132
2023P000785
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The project is a placebo-controlled study that aims to use closed-loop transcranial alternating current stimulation (tACS) to study patients with symptoms of mild cognitive impairment which is likely due to Alzheimer's disease or another form of dementia (AD-MCI). Patients will undergo an EEG and complete some questionnaires and computer tasks during each study visit. The project has the following aims and hypotheses: 1.) To determine the impact of closed-loop 40 Hz tACS on the entrainment of natural gamma rhythms in patients with AD-MCI, 2.) To determine the impact of closed-loop 40 Hz tACS on cognitive performance in patients with AD-MCI, and 3.) To assess the relationship between baseline neurodegenerative burden and impact of tACS. [exploratory]

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely dueto AD (AD biomarker supported)

  • 50-80 years of age

  • English native speakers

Exclusion

Exclusion Criteria:

  • Known presence of a structural brain lesion (e.g., tumor, cortical infarct)

  • Acute or decompensated active medical conditions, including cancer, cardiovasculardisease, stroke, congestive heart failure

  • Active hematological, renal, pulmonary, endocrine or hepatic disorders

  • Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substanceabuse with continuous abuse up to and including the time that the symptoms leadingto clinical presentation developed

  • tACS contraindications (lesions in the scalp, history of seizures)

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: tACS device
Phase:
Study Start date:
January 31, 2025
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Massachusetts General Hospital

    Charlestown, Massachusetts 02129
    United States

    Active - Recruiting

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